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The BAROnova Access Sheath Kit is used in conjunction with an endoscope for procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract, with or without instruments through the instrument chamel of the endoscope. The BAROnova Access Sheath Kit is used in conjunction with the TransPyloric Shuttle Delivery Device to facilitate insertion and positioning of the device during TPS delivery and deployment. The Access Sheath Kit is NOT indicated for foreign body removal or instrument use alongside the endoscope.

The BAROnova Access Sheath Kit includes the following products: - BAROnova Access Sheath (with obturator) - Endoscope (Seal) Cap - Insufflation Syringe The BAROnova Access Sheath consists of a clean, non-sterile mated Obturator/Access Sheath Assembly. The Access Sheath is composed of thinwalled tubing, a handle and a distal cuff and balloon with an atraumatic tip. The Obturator is made of flexible tubing with an atraumatic tip. The Seal Cap consists of a non-sterile, plastic cap for use with standard endoscopes. A 10cc syringe is also provided with the Access Sheath Kit to enable balloon inflation and deflation.